Class II
Terminated
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
- Company
- Hospira Inc., A Pfizer Company
- Recall Initiated
- September 16, 2016
- Posted
- October 19, 2016
- Recall Number
- D-0097-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4768 vials
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 59310DD, Exp 1NOV2017
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